Senior Project Manager / Business Analyst GxP Clinical Solutions (Pharmaceuticals) | 100% Remote US

Job Title: Senior Project Manager / Business Analyst – GxP Clinical Solutions (Pharmaceuticals)
Duration: 6+ Months Contract
Location: 100% Remote
Overview
Seeking a Senior Project Manager / Business Analyst to support strategic Clinical Development Technology initiatives focused on clinical operations, data-driven decision-making, automation, and AI-enabled process improvements. This role combines project leadership, business analysis, stakeholder management, and solution delivery responsibilities across multiple GxP-regulated programs.
The ideal candidate will have strong pharmaceutical industry experience, particularly within Clinical Operations and Clinical Data Management, along with a proven ability to lead cross-functional initiatives from project inception through implementation. This individual will serve as the primary liaison between business stakeholders, product teams, and technology partners to ensure successful delivery of business outcomes.
Key Initiatives
Projects may include:

• Clinical Site Intelligence platform to improve study enrollment timelines and site performance
• Automated Third-Party Data (Non-EDC) Pipeline implementation and optimization
• GUIDE program delivering timely, data-driven feasibility insights to optimize inclusion/exclusion criteria and geographic study strategies

All initiatives will incorporate elements of AI enablement, process optimization, and continuous improvement.
 
Key Responsibilities
Project Management

• Lead end-to-end project planning, execution, monitoring, and delivery across multiple concurrent initiatives.
• Develop and maintain project plans, timelines, milestones, RAID logs, status reporting, and stakeholder communications.
• Facilitate project governance, steering committee updates, and cross-functional decision-making.
• Identify project risks, dependencies, and issues, proactively driving mitigation and resolution activities.
• Coordinate activities across business, technology, testing, data, and vendor teams to ensure successful delivery.
• Drive Agile ceremonies and support hybrid Agile/Waterfall project execution methodologies.

Business Analysis

• Partner with business stakeholders to understand strategic objectives, operational challenges, and technology needs.
• Elicit, document, and manage business requirements, user stories, acceptance criteria, process flows, and functional specifications.
• Analyze current-state and future-state processes to identify opportunities for automation, efficiency gains, and AI-enabled improvements.
• Author and refine system support processes, workflows, configuration documentation, and process interdependencies.
• Translate business requirements into actionable deliverables for development and product teams.
• Facilitate requirements prioritization and backlog management with stakeholders and product owners.

Solution Delivery & Compliance

• Collaborate with testing teams to define, review, and execute User Acceptance Testing (UAT) strategies and scripts.
• Manage UAT activities through defect resolution and release signoff.
• Ensure solutions comply with GxP regulations, Quality Management Systems (QMS), SDLC standards, and internal governance requirements.
• Support change management, training, and adoption activities as needed.
• Maintain comprehensive project and validation documentation in accordance with regulatory expectations.

Stakeholder Engagement

• Build and maintain strong partnerships with business leaders, Clinical Operations teams, Data Management teams, Product Owners, and Technology stakeholders.
• Serve as a trusted advisor and primary point of contact for project and business analysis activities.
• Facilitate workshops, requirements sessions, and solution reviews with global stakeholders.
• Communicate project status, risks, decisions, and recommendations to leadership and cross-functional teams.

Required Qualifications

• Bachelor's degree in Life Sciences, Computer Science, Business, or a related discipline.
• 7–10+ years of pharmaceutical, biotechnology, or CRO industry experience.
• Demonstrated experience performing both Project Management and Business Analysis responsibilities on enterprise-scale initiatives.
• Strong understanding of Clinical Development processes, Clinical Operations, and Clinical Data Management.
• Experience implementing clinical technology solutions in GxP-regulated environments.
• Expertise in requirements gathering, process mapping, user story development, and stakeholder management.
• Experience leading Agile, Waterfall, and hybrid project delivery methodologies.
• Proven ability to manage multiple stakeholders, competing priorities, and complex project dependencies.
• Strong communication, facilitation, and executive presentation skills.

Preferred Qualifications

• Experience supporting Clinical Trial Management, Site Intelligence, Study Feasibility, Clinical Analytics, or Pharmacovigilance initiatives.
• Exposure to AI, advanced analytics, data visualization, and automation projects.
• Familiarity with third-party clinical data integrations and non-EDC data pipelines.
• Experience working within validated GxP environments and computerized system validation processes.
• PMP, PMI-PBA, CBAP, Scrum Master, or similar certifications preferred.

Environment

• Pharmaceutical / GxP-Regulated Environment
• Clinical Development Technology
• Agile & Waterfall Methodologies
• Global Stakeholder Engagement

 


Please apply with your interest. You may also reach out to me at

abaranwal@alphambe.com

 
Thank you,
Ashu
 
We provide a comprehensive package which includes.
Benefits

• Medical for full time employees
• Dental, and Vision Insurance
• Life Insurance, Short-Term Disability, Long-Term Disability, etc.